摘要
目的:评价人绒毛膜促性腺激素测试条(胶体金免疫层析法)的分析性能。方法:主要从灵敏度,特异性,阴性符合率,阳性符合率,HOOK效应和加速稳定性等六方面来评价7个厂家生产的人绒毛膜促性腺激素测试条(胶体金免疫层析法)。结果:在受检的7个厂家中,7种产品的灵敏度分别为12.5mIU/mL(3/7),20mIU/mL(2/7),5mIU/mL(1/7)和低于1mIU/mL(1/7);特异性检测中,仅有1个厂家显示人黄体生成激素对0mIU/mLHCG的检测有干扰,条带显示为弱阳性;7种产品的阴性符合率和阳性符合率均为100%;HCG在浓度高达100,000mIU/mL时无HOOK效应,结果仍显示为阳性或弱阳性;对于加速稳定性检测,测试条在(37±1)·C放置时,其稳定性时间均能超过21d。结论:在人绒毛膜促性腺激素试条(胶体金免疫层析法)的性能评价中,各厂家在一些重要指标上存在差异,有待于建立行业标准进一步统一使其规范化。
Objective: Evaluate the performance characteristics of Human Chorionic Gonadotropin (HCG) strips by Colloidal Gold Immunochromatographic Assay (GICA). Method: Analyze the HCG strips from 7 manufacturers on sensitivity, speciality, the negative percent (%) agreement, the positive percent (%) agreement, HOOK effect and stability. Result: Regarding to the sensitivity , 3 of 7 were 12.5mIU/mL, 2 of 7 were 20mIU/mL, 1 of 7 was 5mIU/mL and 1 of 7 was lower than 1mIU/mL; During the speciality test,only 1 of 7 manu...
出处
《中国医疗器械信息》
2008年第4期19-22,共4页
China Medical Device Information
关键词
人绒毛膜促性腺激素
胶体金免疫层析法
性能评价
Human Chorionic Gonadotropin（Hcg）
Colloidal Gold Immunochromatography
Performance Evaluation
